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Non-Irrigation Endosseous Dental Implant Drill Bits

Page Type
Product Code
Definition
The device is intended to prepare the site for placement of endosseous dental implants. It is to be used at a low speed without irrigation.
Physical State
The device is composed of metal drill bits.
Technical Method
The device incorporates a design/geometry which allows for dental implant site preparation at low speed without irrigation, specific to the surgical protocol of a dental implant system.
Target Area
The device is intended for use in the oral cavity for drilling the bone of the upper and lower jaw.
Regulation Medical Specialty
Dental
Review Panel
Dental
Submission Type
510(K) Exempt
Device Classification
Class 1
Regulation Number
872.3980
GMP Exempt?
No
Summary Malfunction Reporting
Ineligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 872.3980 Endosseous dental implant accessories

§ 872.3980 Endosseous dental implant accessories.

(a) Identification. Endosseous dental implant accessories are manually powered devices intended to aid in the placement or removal of endosseous dental implants and abutments, prepare the site for placement of endosseous dental implants or abutments, aid in the fitting of endosseous dental implants or abutments, aid in the fabrication of dental prosthetics, and be used as an accessory with endosseous dental implants when tissue contact will last less than 1 hour. These devices include drill bits, screwdrivers, countertorque devices, placement and removal tools, laboratory pieces used for fabrication of dental prosthetics, and trial abutments.

(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.

[65 FR 60099, Oct. 10, 2000]

Non-Irrigation Endosseous Dental Implant Drill Bits

Page Type
Product Code
Definition
The device is intended to prepare the site for placement of endosseous dental implants. It is to be used at a low speed without irrigation.
Physical State
The device is composed of metal drill bits.
Technical Method
The device incorporates a design/geometry which allows for dental implant site preparation at low speed without irrigation, specific to the surgical protocol of a dental implant system.
Target Area
The device is intended for use in the oral cavity for drilling the bone of the upper and lower jaw.
Regulation Medical Specialty
Dental
Review Panel
Dental
Submission Type
510(K) Exempt
Device Classification
Class 1
Regulation Number
872.3980
GMP Exempt?
No
Summary Malfunction Reporting
Ineligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 872.3980 Endosseous dental implant accessories

§ 872.3980 Endosseous dental implant accessories.

(a) Identification. Endosseous dental implant accessories are manually powered devices intended to aid in the placement or removal of endosseous dental implants and abutments, prepare the site for placement of endosseous dental implants or abutments, aid in the fitting of endosseous dental implants or abutments, aid in the fabrication of dental prosthetics, and be used as an accessory with endosseous dental implants when tissue contact will last less than 1 hour. These devices include drill bits, screwdrivers, countertorque devices, placement and removal tools, laboratory pieces used for fabrication of dental prosthetics, and trial abutments.

(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.

[65 FR 60099, Oct. 10, 2000]